US Ruling Confirms Copaxone Is Not A Biologic
Legal Fight May Finally Be Over After District Court Ruling
US FDA’s interpretation of ‘protein’ is reasonable and owed deference, the court concludes in tossing Teva suit which challenged Copaxone’s exclusion from list of drugs transitioned to being regulated as biologics.
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Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process
Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.
Sandoz/Momenta’s Glatopa (glatiramer) met four criteria for equivalence that ‘provide overlapping and confirmatory evidence of active ingredient sameness,’ FDA says.
FDA says Teva’s argument to court about dire impact of potential glatiramer ANDAs does not match its statements to investors.